Status:
RECRUITING
New Treatment of Knee Osteoarthritis
Lead Sponsor:
Symatese
Conditions:
Knee Osteoarthristis
Eligibility:
All Genders
35-85 years
Phase:
NA
Brief Summary
Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint margi...
Detailed Description
Pivotal clinical investigation, interventional, prospective, comparative, single-blinded, controlled with two arms, randomized, multicentre clinical trial designed to assess the performance and safety...
Eligibility Criteria
Inclusion
- 1\. Voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
- 2\. Male and female subjects, aged 35 to 85 years (inclusive).
- 3\. Subjects affected by knee osteoarthritis, as defined by American College of Rheumatology (ACR) clinical and radiographic criteria for OA of the knee, and meeting the following conditions:
- Non-severe Grade 2 to 3 osteoarthritis of the knee according to the Kellgren-Lawrence (KL) classification, confirmed by an extension face X-rays shot, supported by flexion face X-rays shot (optional) obtained within 6 months from the screening visit.
- Subjects suffering from OA symptoms of the target knee for at least 6 months prior to the screening visit.
- 4\. Pain during walking on flat ground in the target knee of at least 40 mm and maximum 80 mm on a 0-100 mm VAS at the baseline visit (Visit 2).
- 5\. Subjects in treatment failure of first line treatment with oral NSAIDS
- 6\. Women of childbearing potential must have a negative urine pregnancy test prior to each injection.
- 7\. Subject who is able to comply with the study requirements, at the Investigator\'s appreciation.
Exclusion
- \- 1. Pregnant and breastfeeding women
- 2\. Subject with bilateral OA of the knees is excluded if one of the following points is present on the non-targeted knee has:
- a visual analog scale (VAS) score greater than 30mm (\> 30mm),
- a KL score is greater than 2 (\>2)
- a dedicated pain relief medicine consumption.
- 3\. Subject suffering from a severe or progressive disease or any other pathology which, according to the investigator, may interfere with evaluation of the results of the study: diabetes, autoimmune pathology, cardiac pathologies, hepatic deficiency, epilepsy, porphyria, rheumatoid arthritis or other systemic inflammatory process.
- 4\. Subject who has a known history of severe multiple allergies, angioedema or anaphylactic shock according to the investigator opinion.
- 5\. Subject with a known allergy or hypersensitivity to Hyaluronic Acid or bovine collagen.
- 6\. Subject with a past history of severe streptococcal disease or an active streptococcus infection according to the investigator opinion.
- 7\. Subject with an infections, inflammation or skin diseases in the area of the injection site.
- 8\. Subject with a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
- 9\. Subject having received chemotherapy agents, immunosuppressive medications within the past 3 months.
- 10\. Subject with bleeding disorders or subject having received medication (anti-platelet agents and anticoagulant) that will likely increase the risk of bleeding within the past 24 hours before injections.
- 11\. Subjects having received:
- Intra-articular steroid injections within 60 days of the baseline visit or during study participation. Oral corticosteroids within four weeks of the screening visit or during study participation.
- Chondroitinsulphate, glucosamine sulphate, diacereine, bisphosphonates or matrix metalloproteinase (MMP) inhibitors within 30 days prior to the baseline visit.
- Viscosupplementation of the target knee within 6 months prior to the baseline visit.
- Any kind of pain relief medicine and NSAIDs in the 24 hours prior to the baseline visit (V2).
- 12\. Subjects with a KL grade 4 patellofemoral osteoarthritis or subjects with a patellofemoral osteoarthritis KL grade higher than the femora-tibial one.
- 13\. Subjects with coxarthrosis. 14. Subjects having had any previous surgery in the target knee within 6 months prior to the screening visit, or any planned surgery in the target knee throughout the duration of the investigation.
- 15\. Subjects who have had arthroplasty at the target knee at any time. 16. Subjects having had diagnostic or surgical knee arthroscopy, or knee lavage in the target knee in the 6 months prior to the screening visit.
- 17\. Subjects that are candidate for knee replacement within the study period. 18. Subjects with body mass index (BMI) \> 35 kg/m2. 19. Subjects with large intra-articular effusion of the target knee, venous or lymphatic stasis, inflammatory flare-up with various symptoms, local inflammation.
- 20\. Subjects with history of septic OA of any joint 21. Subjects with significant pain outside the target knee, including significant hip or back pain and with fibromyalgia.
- 22\. Subjects with clinically significant valgus/varus deformities, ligamentous laxity, or meniscal instability as assessed by the Investigator.
- 23\. Subjects with other musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee (e.g. Paget's disease of bone).
- 24\. Subjects with a current malignancy or having treatment for a malignancy, except non-melanoma skin cancer.
- 25\. Subjects with drug or alcohol abuse 26. Subject who is deprived of their freedom by administrative or legal decision.
- 27\. Subject living in a social or sanitary establishment. 28. Subject being in an exclusion period for a previous study or with a current or recent (\<3 months) participation in another investigational study involving a drug or combined device with drug.
- 29\. Other condition preventing the subject to participate the study in the Investigator's opinion: subject deemed unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment results.
Key Trial Info
Start Date :
February 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06611098
Start Date
February 21 2025
End Date
March 1 2026
Last Update
February 26 2025
Active Locations (2)
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1
IRIS CRO
Mtskheta, Georgia, Georgia, 3300
2
IRIS CRO
Riga, Latvia, Latvia, 1002